The Early Positive Approaches to Support (E-PAtS) study: study protocol for a feasibility cluster randomised controlled trial of a group programme (E-PAtS) for family caregivers of young children with intellectual disability

Pilot and Feasibility Studies

Richard Hastings¹  Geoff Lindsay¹  David Gillespie²  Kerry Hood²  Elinor Coulman²  Rachel McNamara²  Fiona Lugg-Widger²  Michael Robling²  Jeremy Segrott³  Vaso Totsika⁴  Andrew Jahoda⁵  Jacqui Shurlock⁶  Jill Bradshaw⁷  Nick Gore⁷  Stavros Petrou⁸ 

[1] Centre for Educational Development Appraisal and Research, University of Warwick, CV4 7AL, Coventry, UK;Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, CF14 4YS, Cardiff, UK;DECIPHer Centre Cardiff University, 1-3 Museum Place, CF10 3BD, Cardiff, UK;Division of Psychiatry, Faculty of Brain Sciences, University College London, Wing B, Maple House, Tottenham Court Road, London, UK;Institute of Health and Wellbeing, University of Glasgow, G12 8RZ, Glasgow, UK;The Challenging Behaviour Foundation, The Old Courthouse, New Road Avenue, Chatham, ME4 6BE, Kent, UK;Tizard Centre, University of Kent, Cornwallis North East, CT2 7NF, Canterbury, UK;Warwick Clinical Trials Unit, University of Warwick, CV4 7AL, Coventry, UK;

关键词: Intellectual disability;    Learning disability;    Support;    Randomised controlled trial;    Feasibility;    Early Positive Approaches to Support (E-PAtS);    Mental wellbeing;   

DOI  :  10.1186/s40814-020-00689-9

来源: Springer

【 摘 要 】

BackgroundChildren with intellectual disability have an IQ < 70, associated deficits in adaptive skills and are at increased risk of having clinically concerning levels of behaviour problems. In addition, parents of children with intellectual disability are likely to report high levels of mental health and other psychological problems. The Early Positive Approaches to Support (E-PAtS) programme for family caregivers of young children (5 years and under) with intellectual and developmental disabilities is a group-based intervention which aims to enhance parental psychosocial wellbeing and service access and support positive development for children. The aim of this study is to assess the feasibility of delivering E-PAtS to family caregivers of children with intellectual disability by community parenting support service provider organisations. The study will inform a potential, definitive RCT of the effectiveness and cost-effectiveness of E-PAtS.MethodsThis study is a feasibility cluster randomised controlled trial, with embedded process evaluation. Up to 2 family caregivers will be recruited from 64 families with a child (18 months to 5 years) with intellectual disability at research sites in the UK. Participating families will be allocated to intervention: control on a 1:1 basis; intervention families will be offered the E-PAtS programme immediately, continuing to receive usual practice, and control participants will be offered the opportunity to attend the E-PAtS programme at the end of the follow-up period and will continue to receive usual practice. Data will be collected at baseline, 3 months post-randomisation and 12 months post-randomisation. The primary aim is to assess feasibility via the assessment of: recruitment of service provider organisations; participant recruitment; randomisation; retention; intervention adherence; intervention fidelity and the views of participants, intervention facilitators and service provider organisations regarding intervention delivery and study processes. The secondary aim is preliminary evaluation of a range of established outcome measures for individual family members, subsystem relationships and overall family functioning, plus additional health economic outcomes for inclusion in a future definitive trial.DiscussionThe results of this study will inform a potential future definitive trial, to evaluate the effectiveness and cost-effectiveness of the E-PAtS intervention to improve parental psychosocial wellbeing. Such a trial would have significant scientific impact internationally in the intellectual disability field.Trial registrationISRCTN70419473

【 授权许可】

CC BY